Chinese traditional medicine can be available in the United States!? Take stock of FDA-listed plant medicines

original title: Chinese traditional medicine can be listed in the United States!? Taking stock of the U.SFDA-listed plant medicinefrom the Outline of the Chinese Medicine Development Strategy Outline (2016-2030), the "Healthy China 2030" Outline to the Chinese Medicine Law and the "Belt and Road Development Plan for Chinese Medicine" (2016-2020), it is not difficult to see that the state's support for the Chinese medicine industry is unprecedentedThe FDA is synonymous with the authority to approve drugs, but so far no domestic Chinese traditional medicine is listed in the U.SFDAIn this, small compilation of the FDA listed only two plant drugs, hoping to give the domestic chinese medicine modernization workers a little inspirationFirst FDA-listed plant drug: Green tea extract Veregen
In October 2006, the FDA approved Veregen (tea polyphenol) as a new prescription drug for local (external) treatment of genital warts caused by human papillomavirusThis is the first plant (herb) drug approved by the FDA under the 1962 Pharmaceutical Amendment RegulationsThis is a very Chinese-chinese quasi-Chinese medicine, its clinical research to the successful listing can not be separated from the unknown scientist Cheng Shuxuan academician behindfrom Cheng Shuxuan began to study tea polyphenols, to the founding of this "milestone" has been more than 20 years, now, most people are most concerned about the topic is: how to win the FDA approval of tea polyphenols? "This is the result of a long and complex international cooperation, but every step is natural, and I have never asked for it, " cheng saidFrom the beginning of the study of green tea catechin anti-mutation, anti-cancer mutation and its mechanism, it is proved that green tea catechin has obvious inhibition of skin inflammation, hyperplasia, inhibit the occurrence of skin papilloma and so onTo follow up with foreign companies to apply for national patents, promote clinical trials, and ultimately successfully marketed in multiple countries or regions (including the United States)This is cheng Shuxuan in the 1990s developed a combination of drugs for the treatment of warts, transferred to the German company MediGene, after years of international cooperation, and finally applied for a new drug in the United States FDA, the invention of this drug from their 20 years of experimental research and clinical researchEffectiveness and safety are supported by a number of clear clinical data that have allowed the drug to successfully conquer the FDA, as can be seen in the hardships2, the first oral plant prescription drug: Fulyzaq
On December 31, 2012, the FDA approved the listing of Salix Pharmaceuticals' oral plant drug, The Drug Crofelemer," which can be used to relieve non-infectious diarrhea symptoms in HIV/AIDS patients receiving antiretroviral (ART) therapy This is the second plant drug approved since the FDA approved the first plant drug, Veregen, after the FDA approved the first plant drug, Veregen, a mixture of catechins and other green tea components derived from green tea, and The first oral plant drug approved by the FDA Crofelemer is derived from the red latex of the babe plant lechleri When the bark is cut, a red, blood-like-like latex that contains a new multimolecular structure substance, Crofelemer Crofelemer is a plant drug extracted from the red juice of the Crotonlechleri M?ll.Arg., which is a mixture of pro-ant hocyanidin, aggregated and aggregated in four monomers The safety and effectiveness of Fulyzaq has been confirmed in clinical studies, according to the FDA The study, conducted in South America, involved 374 HIV-positive patients who received stable ART therapy and had a history of diarrhea for more than one month (cases of diarrhoea caused by infection or gastrointestinal disease) with a history of diarrhea that had been rejected; The trial randomly divided the patients into the Fulyzaq group and the placebo group, and was given twice a day The end of clinical effectiveness was determined by the proportion of patients who developed watery diarrhea symptoms no more than twice a week in a placebo-control study (four weeks) for at least two weeks The results showed that 17.6 percent of patients who were treated with Fulyzaq had a clinical response, significantly higher than the 8 percent response rate in the placebo group; In March 2016, Napo Pharmaceuticals withdrew its rights to the production and sale of Fulyzaq (previously developed and produced by Salix Pharmaceuticals) The study of clinical trial data in Fulyzaq III suggests that Fulyzaq, as an anti-secretion, anti-diarrhea preparation, mainly acts on the gastrointestinal cavity and has fewer systemic features Studies have confirmed that the secretion of chloride ions can lead to diarrhea, accompanied by dehydration, electrolyte disorders, abdominal cramps and other symptoms At the recommended dose (125mg reprieve, 1 tablet/time, 2 times/day), Fulyzaq simultaneously inhibits cAMP-activated cystic fibrosis transmembrane transduction regulator (CFTR) chlorine ion channel and calcium activates the chloride ion channel (CaCC), by inhibiting the secretion of chloride ions to the intestines to reduce the secretion of water from the circulatory system to the intestinal cavity, thereby alleviating the patient's diarrhea symptoms Clinical studies have shown that, unlike other anti-diarrhea preparations, Fulyzaq does not affect intestinal peristalsis and the effectiveness and safety of patients taking HIV medications However, before using Fulyzaq treatment, health care providers must conduct appropriate tests to determine that the diarrhea is not caused by an infection or gastrointestinal disease According to clinical studies, the most common adverse reactions in patients taking Fulyzaq were upper respiratory tract infections, bronchitis, coughing, bloating of the gastrointestinal, and elevated levels of bilirubin 3, in the United States to conduct clinical trials of domestic Chinese traditional medicine according to incomplete statistics, has submitted to the U.S FDA IND application of Traditional Chinese medicine is: note: data from the 2017 China Pharmaceutical Industry Internationalization Blue Book, for reference pictured above are 10 chinese-made Chinese medicines conducted in clinical trials in the United States, and according to the latest data, there has been little progress in its research and development In the first place, the first compound Dansan drop pills are the most concerned about the Chinese medicine, in September 2017, Li Li Lianda academician and Tian Shili on the compound Dansan drop pills u.S FDA declared registration clinical phase III trial results of the problem brush screen medicine circle, both sides of the word, good or not lively As early as 1996, the compound Dansan drop pill was selected as the first case of compound Chinese medicine declared by the United States FDA, to 2006 Tianshili the second time to apply to the FDA for a new IND, clearly to prevent and treat chronic stability angina as an indication, which is by far the fastest internationalization of Chinese medicine varieties Whether it can finally be listed in the United States is a milestone event related to the internationalization of Chinese medicine in China However, 2018 is coming to an end, the relevant conclusions have not been able to cover the coffin, whether the domestic Chinese traditional medicine can make history, the FDA's approval, still need time to verify four or two plant drugs approved by the FDAfor the revelation
The FDA is very cautious about approving multi-component plant medicines, and manufacturers of plant pharmaceutical products must ensure strict quality control of raw materials, perform ingresswith production practices for planting and harvesting, and perform analytical tests of complex mixtures Therefore, China's plant medicine (such as the clinical stage of HMPL-004) want to enter the international market is not easy, from the chinese medicine to the finished product of the whole process needs to carry out strict quality control, while focusing on safety and efficacy research, combined with international plant medicine research experience, choose the right indications and dosage forms for development The efficacy of green tea extract was first discovered by Chinese scholars, Professor Cheng Shuxuan, and published in international journals in the form of papers However, the late-stage research and development of the product by Japan, Germany and other parties to complete, and eventually marketed in the United States, become the first FDA approved plant medicine, other such as yew alcohol Ignoring the result of the link between basic research and industrialization is to make a wedding dress for outsiders Domestic enterprises should attach importance to the integration of production, research and research, on the basis of in-depth product research, the industrialization of solid varieties to promote the work, to fully use the experimental data to speak, relying on clear effectiveness and safety to conquer the judges of the review and approval, rather than relying on feelings, philosophy or culture to develop Chinese medicine May Chinese medicine be carried forward in the hands of my generation reference: Pharmaceutical Melt data, Pharnex Datamonitor; pharmaceutical melt